A Study in Healthy Men to Test How Well Different Doses of BI 1839100 Are Tolerated (1490-0001)
NCT ID: NCT05354453
Last Updated: 2023-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
104 participants
INTERVENTIONAL
2022-05-23
2023-06-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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SRD Part
Single-rising dose (SRD)
BI 1839100
BI 1839100
SRD Part: Placebo
Placebo
Placebo
Skin Challenge Part
BI 1839100
BI 1839100
allyl isothiocyanate (AITC)
allyl isothiocyanate (AITC)
Skin Challenge Part: Placebo
Placebo
Placebo
allyl isothiocyanate (AITC)
allyl isothiocyanate (AITC)
Interventions
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BI 1839100
BI 1839100
Placebo
Placebo
allyl isothiocyanate (AITC)
allyl isothiocyanate (AITC)
Eligibility Criteria
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Inclusion Criteria
* Age of 18 to 45 years (inclusive)
* Body mass index (BMI) of 18.5 to 31.9 kg/m2 (inclusive)
* Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
* Male subjects who meet any of the following criteria for a highly effective contraception from the first administration of trial medication until 90 days after trial completion:
* Willing to use a medically accepted method of contraception. Acceptable methods of contraception for use by male subjects include sexual abstinence, a vasectomy performed at least 1 year prior to dosing, and barrier contraception (condom)
* Subjects who are not vasectomised or sexually abstinent have to ensure that an additional acceptable method of contraception (in addition to male condom) will be used by his female partner such as intrauterine device (IUD), surgical sterilisation (including hysterectomy), hormonal contraception (e.g. implants, injectables, combined oral or vaginal contraceptives) that started at least 2 month prior to drug administration or postmenopausal status of female partner (defined as no menses for 1 year without an alternative medical cause (in questionable cases a blood sample with follicle stimulating hormone (FSH) above 40 U/L and estradiol below 30 ng/L is confirmatory)
Exclusion Criteria
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm (subjects with heart rate values between 45 and 50 bpm may only be enrolled in case they have a normal thyroid function, no clinical symptoms associated with the bradycardia and no apparent signs of other diseases causing bradycardia such as hypothyroidism or heart conduction abnormalities)
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease assessed as clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
18 Years
45 Years
MALE
Yes
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Locations
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Centre Human Drug Research
Leiden, , Netherlands
Countries
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Related Links
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Related Info
Other Identifiers
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2021-006294-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1490-0001
Identifier Type: -
Identifier Source: org_study_id
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